Training and Quality Consultant Manager

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.

Currently, one of our clients in the pharmaceutical/medical devices sector is looking to hire a Training Manager Consultant in El Paso, Texas.

Responsibilities

Program Management

• Provide leadership and oversight for the site Training Department.
• Develop and execute a comprehensive site training strategy aligned with business objectives and regulatory requirements.
• Manage training personnel and ensure effective delivery of onboarding, technical, GMP, and compliance-based training programs.
• Establish training governance, metrics, and reporting mechanisms.

Training System Assessment & Improvement

• Conduct a comprehensive assessment of the site's current training system and identify compliance gaps, process improvement opportunities, and best practices.
• Develop and implement remediation and enhancement plans to strengthen training effectiveness and compliance.
• Ensure alignment with corporate policies, procedures, and regulatory expectations.

Compliance Tracking & Documentation

• Design and implement systems to maintain accurate training records, qualification matrices, and training curricula.
• Monitor training compliance and ensure employees remain current with required training assignments.
• Develop dashboards and metrics to track training completion, effectiveness, and compliance status.

Audit Readiness

• Prepare and maintain training documentation, qualification records, and employee training files for internal and external audits.
• Support FDA inspections, customer audits, and regulatory agency reviews.
• Ensure training systems continuously meet GMP, GDP, and quality system requirements.

SOP Administration

• Partner with department leaders to write, revise, review, and maintain Standard Operating Procedures (SOPs) related to quality and manufacturing processes.
• Ensure training curricula are updated to reflect procedural changes and regulatory updates.
• Promote document control and training compliance across the organization.

Training Effectiveness & Continuous Improvement

• Evaluate the effectiveness of training programs using performance metrics and quality indicators.
• Measure knowledge transfer and training impact through error rates, deviations, investigations, CAPAs, and operational performance trends.
• Recommend and implement improvements to drive workforce capability and operational excellence.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Education, Training & Development, Quality, or a related discipline.
• 5 years of experience in Training, Quality Systems, Learning & Development, or Compliance within the Medical Device, Pharmaceutical, Biotechnology, or other FDA-regulated manufacturing environments.
• Fully Bilingual - Spanish & English
• Strong knowledge of FDA regulations, GMPs, Quality Systems, and regulatory inspection readiness.
• Experience developing, implementing, and managing site-wide training programs and compliance systems.
• Proven experience supporting audits, inspections, CAPAs, and quality improvement initiatives.
• Experience writing, reviewing, and implementing SOPs and controlled documentation.
• Strong leadership, project management, and stakeholder management skills.
• Excellent communication, organizational, and analytical abilities.

Please note: This position does not offer visa sponsorship and candidate from third parties companies are not allowed. Kindly refrain from applying if you do not meet these requirements.

Work Location: In person

Salary : $45,975 - $80,382